Status:
RECRUITING
Asian Diabetes Outcomes Prevention Trial
Lead Sponsor:
National Heart Centre Singapore
Collaborating Sponsors:
Singapore General Hospital
Mackay Memorial Hospital
Conditions:
Diabetes Mellitus
Cardiovascular Diseases
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief Summary
The aim of this study is to identify patients with DM at high risk of CVD using elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels (\>125pg/mL), and (2) intensify therapy using reni...
Detailed Description
Rationale: Cardiovascular events are the leading cause of death among patients with diabetes. Early identification of high-risk diabetic (DM) patients for intensification of preventive therapy may pr...
Eligibility Criteria
Inclusion
- Type 2 diabetes for at least six months
- ≥ 40 years of age, men or women
- No known cardiovascular disease ( defined as known coronary stenosis \> 70%, reduced left ventricular ejection fraction \< 40%, or a history of myocardial infarction/ coronary revascularization/ heart failure hospitalization/ stroke/ prior non-traumatic lower limb amputation or angioplasty)
- NT-proBNP \> 125 pg/mL
- Written informed consent
Exclusion
- History of hypersensitivity to any of the drugs investigated as well as known or suspected contraindications to the study drugs or previous history of intolerance
- Patients already on a maximum dose of RAASi or beta-blocker
- History of DM ketoacidosis/Type 1 DM
- eGFR \< 45ml/min/1.73m2
- Symptomatic hypotension and/or Visit 1 systolic blood pressure (SBP) \< 100mmHg.
- Symptomatic bradycardia, high-grade AV blocks (Grade 2 and 3) and/or Visit 1 heart rate (HR) \< 60bpm.
- Any disease other than diabetes lowering the patient's life expectancy to less than two years.
- Chronic infections (E.g. chronic cystitis, recurrent urinary tract infections) or malignancies or uncontrolled thyroid disorder or liver disease
- Systemic treatment with corticosteroids.
- Pregnant or nursing women
- Any other clinical condition that might affect patients' safety during trial, at the investigator's discretion.
- Participation in an investigational drug trial
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2034
Estimated Enrollment :
2400 Patients enrolled
Trial Details
Trial ID
NCT04286399
Start Date
July 1 2019
End Date
June 30 2034
Last Update
April 30 2021
Active Locations (1)
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1
Singapore General Hospital (SGH)
Singapore, Singapore, 169608